The European Medicines Agency (EMA) has revised its guidance on the publication of clinical data that came into effect in October of this year. The revised guidance contains a number of changes including:
• Clarification that all clinical reports submitted or cross-referenced in a regulatory application will be published following the redaction of commercially confidential information (CCI) and protected personal data (PPD).
• Information on how sponsors should manage the removal of “out of scope” individual patient data from clinical study reports
• How the agency will handle incomplete redaction proposals
• How sponsors should distinguish between redacted CCI and PPD within their documents.
Thus far, the EMA has published clinical data for four drugs: Armisarte (pemetrexed diacid monohydrate) and Caspofungin Accord (caspofungin acetate) published on 24th November 2016, Kyprolis (carfilzomib) and Zurampic (lesinurad) published on 20th October 2016.